sotalol

Generic: sotalol hydrochloride

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotalol
Generic Name sotalol hydrochloride
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotalol hydrochloride 80 mg/1

Manufacturer
UNICHEM PHARMACEUTICALS (USA), INC.

Identifiers & Regulatory

Product NDC 76385-114
Product ID 76385-114_fe9ac463-547d-4917-a98e-61f1c0fe38f1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207428
Listing Expiration 2027-12-31
Marketing Start 2017-12-15

Pharmacologic Class

Classes
adrenergic beta-antagonists [moa] antiarrhythmic [epc] cardiac rhythm alteration [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76385114
Hyphenated Format 76385-114

Supplemental Identifiers

RxCUI
1922720 1922763 1922765 1923422 1923424 1923426
UNII
HEC37C70XX

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sotalol (source: ndc)
Generic Name sotalol hydrochloride (source: ndc)
Application Number ANDA207428 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (76385-114-01)
  • 500 TABLET in 1 BOTTLE, PLASTIC (76385-114-50)
source: ndc

Packages (2)

76385-114-01 100 TABLET in 1 BOTTLE, PLASTIC (76385-114-01) 76385-114-50 500 TABLET in 1 BOTTLE, PLASTIC (76385-114-50)

Ingredients (1)

sotalol hydrochloride (80 mg/1)

Linked Drug Pages (1)

Sotalol, Sotalol Hydrochloride AF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fe9ac463-547d-4917-a98e-61f1c0fe38f1", "openfda": {"unii": ["HEC37C70XX"], "rxcui": ["1922720", "1922763", "1922765", "1923422", "1923424", "1923426"], "spl_set_id": ["56879738-8662-4f5c-8386-761ab2b5e46f"], "manufacturer_name": ["UNICHEM PHARMACEUTICALS (USA), INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (76385-114-01)", "package_ndc": "76385-114-01", "marketing_start_date": "20171215"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (76385-114-50)", "package_ndc": "76385-114-50", "marketing_start_date": "20171215"}], "brand_name": "Sotalol", "product_id": "76385-114_fe9ac463-547d-4917-a98e-61f1c0fe38f1", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "76385-114", "generic_name": "Sotalol Hydrochloride", "labeler_name": "UNICHEM PHARMACEUTICALS (USA), INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sotalol", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "80 mg/1"}], "application_number": "ANDA207428", "marketing_category": "ANDA", "marketing_start_date": "20171215", "listing_expiration_date": "20271231"}